Warner Margaret R, Wolka Anne M, Noel Rebecca A
1 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Ther Innov Regul Sci. 2016 May;50(3):342-346. doi: 10.1177/2168479015609650.
In 2012, the International Conference on Harmonisation (ICH) E2C (R1) guideline for periodic safety update reporting (PSUR) for medicines was revised. Several new concepts that expanded the scope of the report were added, including a new section focused on benefits and an additional section focused on integrated benefit-risk (B-R) assessment. These changes are reflected in the new title of the report, namely, the Periodic Benefit-Risk Evaluation Report (PBRER). Recently, structured frameworks have been developed by the pharmaceutical industry and regulatory agencies to facilitate B-R analysis for medicines.
This manuscript provides suggestions for incorporating the elements of a structured B-R assessment into the PBRER and also includes practical approaches for implementing the ICH guidelines for the B-R analysis section.
The main components of a B-R assessment for the PBRER include decision context; key benefits and key risks; strengths, limitations, and uncertainties of the evidence; risk management; and the overall B-R conclusions.
A structured, systematic approach to defining a medicine's B-R profile will help ensure compliance with this ICH objective for the PBRER.
2012年，国际协调会议（ICH）关于药品定期安全性更新报告（PSUR）的E2C（R1）指南进行了修订。新增了几个扩大报告范围的新概念，包括一个关注获益的新章节和一个关注综合获益-风险（B-R）评估的附加章节。这些变化反映在报告的新标题中，即定期获益-风险评估报告（PBRER）。最近，制药行业和监管机构已制定结构化框架，以促进药品的B-R分析。
本手稿为将结构化B-R评估的要素纳入PBRER提供建议，并包括实施ICH关于B-R分析章节指南的实用方法。
PBRER的B-R评估的主要组成部分包括决策背景；关键获益和关键风险；证据的优势、局限性和不确定性；风险管理；以及总体B-R结论。
采用结构化、系统的方法来定义药品的B-R概况将有助于确保符合ICH对PBRER的这一目标。
